About Amgen
Amgen discovers, develops, and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realise the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient.
Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.
About the Role
The Sr. Automation Engineer will be a member of the team supporting the day-to-day operation of complex automation systems at Amgen Dun Laoghaire (ADL), a 37,000 square meter aseptic drug product operations facility specialising in secondary manufacturing activities - Formulation, Vial/Syringe Filling, Lyophilisation, Inspection and Packaging.
Key Responsibilities
* Safety: Support a safe working environment by complying with all pertinent environmental health/safety practices and regulations.
* Maintenance: Be the System Owner for automation systems in a GMP-regulated manufacturing setting, ensuring systems are maintained in the validated state.
* Investigation: Lead and support incident investigations and troubleshooting efforts related to manufacturing automation systems.
* Improvement: Implement improvements related to corrective or preventative actions, including software changes and updates to design documentation and standard operating procedures.
* Innovation: Analyse the design of current systems, to recommend continuous improvements in line with the latest technology and regulatory standards.
* New Product/Technology Introductions: Support new product or technology introductions by performing engineering assessments, implementing automation system changes and supporting engineering runs.
Requirements
* Bachelor's degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering.
* 5+ years' experience in operations/manufacturing environment.
* Background in automation design, installation, programming.
* Experience with validation and lifecycle maintenance an advantage.
* Experience in one of the following automation specialties an advantage: Building Management Systems (Siemens Desigo), Biopharmaceutical Formulation and/or Fill/Finish (Rockwell or Siemens PLC based), Inspection or Packaging facilities (Rockwell or Siemens PLC based).
* Knowledge of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards, 21 CFR Part 11 and Annex 11.
* Working knowledge of network architecture technologies including TCP/IP and Firewalls.
* Independent, self-motivated, organised and able to multi-task in a manufacturing environment.
* Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
* Solid technical writing, and communication/presentation skills.
* Proficient in managing relationships with stakeholders; coordinating and collaborating with teams from different departments to achieve common goals.